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Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus Intestinal Carriage

Information source: University Hospital, Clermont-Ferrand
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vancomycin Resistant Enterococcus Intestinal Carriage

Intervention: Lactobacillus casei rhamnosus (strain Lcr 35 LC) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Clermont-Ferrand

Official(s) and/or principal investigator(s):
Olivier LESENS, Principal Investigator, Affiliation: University Hospital, Clermont-Ferrand

Overall contact:
Olivier LESENS, Email: olesens@chu-clermontferrand.fr

Summary

This study aims to reduce the duration of VRE intestinal carriage by the administration of Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks regimen with placebo. A stool culture will be performed every week for 5 weeks (during the administration of treatment) then every two weeks until 3 consecutive negative stool culture for VRE.

Clinical Details

Official title: Impact of Probiotic Regimen on Vancomycin Resistant Enterococcus (VRE) Intestinal Carriage : a Double Blind Randomized Pilot Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver)

Primary outcome: Reduction of the duration of Vancomycin Resistant Enterococcus intestinal carriage.

Detailed description: This study aims to reduce the duration of VRE intestinal carriage by the administration of Lactobacillus casei rhamnosus (strain Lcr 35 LC). Patients will be blindly randomized to be assigned to a 5 weeks regimen with the probiotic (10 9 lactobacillus bid) or to a 5 weeks regimen with placebo. A stool culture will be performed every week for 5 weeks (during the administration of treatment) then every two weeks until 3 consecutive negative stool culture for VRE.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age >18;

- Vancomycin Resistant Enterococcus intestinal carriage

Exclusion Criteria:

- Neutropenia <1000 /mm3,

- Immunosuppressive drugs,

- Inhalation

Locations and Contacts

Olivier LESENS, Email: olesens@chu-clermontferrand.fr

Service des Maladies infectieuses et tropicales, Hôpital Gabriel Montpied, Clermont-Ferrand 63003, France; Recruiting
Additional Information

Starting date: February 2007
Last updated: January 18, 2011

Page last updated: August 23, 2015

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